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NCT00006190 · ClinicalTrials.gov registry record · Phase 4
A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy
A Phase 4 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 4
- Development phase
NCT00006190 is a Phase 4 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
The verdict
NCT00006190, a Phase 4 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 4
- Development phase
Study Summary
HIV infection is a major global health problem. Survival and quality of life for HIV subjects has tremendously improved with the advent of a class of antivirals called protease inhibitors and the utilization of highly active combination therapy. However, such therapy has been associated with a syndrome called lipodystrophy. This lipodystrophy syndrome causes body shape changes; typically thinning and loss of fat from the arms, legs and face, with increased fat appearing in the abdomen and neck. There are also metabolic changes which occur, and subjects can develop increased triglycerides, increased cholesterol and an increased risk for diabetes as indicated by increasing insulin resistance. This study will take HIV positive subjects who have not yet started antiviral medications (treatment naive)and randomly assign them to one of two treatment arms. These treatment arms will be: Sustiva/Zerit/Epivir vs. Viracept/Zerit/Epivir The subjects will be treated and followed for two years and have extensive metabolic testing, skinfold thickness measurements, MRI scans and other measures to determine if and how they are experiencing changes in metabolism or body shape and to discover the mechanism of why this occurs. Understanding the mechanism should allow researchers to design interventions for subjects who have lipodystrophy and strategies to prevent lipodystrophy from occurring to subjects treated with antivirals in the future.
Interventions
- DRUG Lamivudine
- DRUG Efavirenz
- DRUG Stavudine
- DRUG Nelfinavir mesylate
Trial Details
| Field | Value |
|---|---|
| Start Date | 2000-11 |
| Est. Completion | 2001-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006190
The ClinicalTrials.gov registry entry for NCT00006190 describes a study currently listed as completed, categorized as Phase 4. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Lamivudine is the first listed.
NCT00006190 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00006190 about?
NCT00006190 is a clinical study titled "A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy". HIV infection is a major global health problem. Survival and quality of life for HIV subjects has tremendously improved with the advent of a class of antivirals called protease inhibitors and the utilization of highly active combination therapy. However, such therapy has been associated with a syndr...
What is the current status of trial NCT00006190?
This trial is currently completed. It is a Phase 4 study. The study started on 2000-11. Estimated completion is 2001-11.
What interventions are being tested in trial NCT00006190?
The interventions under investigation include: Lamivudine (DRUG), Efavirenz (DRUG), Stavudine (DRUG), Nelfinavir mesylate (DRUG).
Who is sponsoring clinical trial NCT00006190?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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